The evolution of modern mass spectrometry (MS) as well the hyphenation of MS to a broad range of analytical separation techniques used in biopharma development has fueled a strong development in analytical tools for physicochemical characterization.
- Solving Bioassay Challenges for Cell & Gene Therapies
- Financial Market Tumult Shows The Need For Creative Funding For Life Sciences
- Mold Investigations Using Biofluorescent Particle Counting Systems
- FDA Updates Guidance For Investigating OOS Test Results
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- How Can We Create A More Perfect CDMO?
- Unlocking New Insights And Treatments For Genetic Eye Diseases: ADOA
Financial Market Tumult Shows The Need For Creative Funding For Life Sciences
Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
Mold Investigations Using Biofluorescent Particle Counting Systems
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.
FDA Updates Guidance For Investigating OOS Test Results
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
Unlocking New Insights And Treatments For Genetic Eye Diseases: ADOA
This article explores how ADOA (Autosomal Dominant Optic Atrophy) occurs, and why it has become a promising target for new approaches to treatment.
FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
How To Navigate Drug Repurposing And Bridging Studies
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
PHARMA OUTSOURCING WHITE PAPERS
Formulation Development Strategy For Early Phase Human Studies
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
High Potency Drug Manufacturing: Molecule To Market
The pharmaceutical landscape continues to evolve, with much R&D focusing on more specialized medicines. As the biological activity and specificity of the API increases, dosage strengths decrease – resulting in increased potency of the APIs in terms of occupational handling for drug product manufacture. This paper examines the process of successful high potency drug manufacturing and delivery to market.
Accelerating The Development Of Oncology Medicines
Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.
Strategies For Upstream Intensification
Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!
Patient-Centric Oral Solid Dose Formulation: Improving Access And Value Across The Product Lifecycle
Gain insight into the systematic application of patient centricity to the design of OSD products.
9 Pitfalls To Avoid During The Document Control Process
In order for the document control process to be a smooth ride to a successful product launch, you need effective control in every phase of the life cycle of every important document. In this white paper, we discuss common issues in every phase of the life cycle of a document.